Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE
Teva Pharma B.V.
A06AD65
MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE
13.8 Grams
Powder for Oral Solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives
Authorised
2014-02-28
Macrogol, UK/H/5431/01, 29.11.16 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LAXATEV 13.8 G POWDER FOR ORAL SOLUTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What _Laxatev_ is and what it is used for 2. What you need to know before you take _Laxatev_ 3. How to take _Laxatev_ 4. Possible side effects 5. How to store _Laxatev_ 6. Contents of the pack and other information 1. WHAT LAXATEV IS AND WHAT IT IS USED FOR The name of this medicine is _Laxatev 13.8 g powder for Oral Solution_. It is a laxative for the treatment of chronic constipation and of very bad constipation (called faecal impaction) in adults, adolescents and elderly. It is not recommended for children below 12 years of age. _ _ It helps you to have a comfortable bowel movement even if you have been constipated for a long time. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _LAXATEV_ DO NOT TAKE _LAXATEV_ - if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6) - if you have a perforated gut (bowel) wall - if you have a blockage in your intestine (gut obstruction, ileus) - if you have severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon. WARNINGS AND PRECAUTIONS When taking _Laxatev_ you should continue to take plenty of fluids. The fluid content of _Laxatev_ should not replace your regular liquid intake. OTHER MEDICINES AND _LAXATEV_ Tell your doctor or pharmacist if you are Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Laxatev 13.8g Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: Macrogol 3350 13.125 g Sodium chloride 0.3507 g Sodium hydrogen carbonate 0.1785 g Potassium chloride 0.0466 g The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows: Sodium 65 mmol/l Chloride 53 mmol/l Hydrogen carbonate 17 mmol/l Potassium 5 mmol/l Excipient with known effect: sorbitol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Oral Solution Single-dose sachet containing a free flowing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation. For the treatment of faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology:_ CHRONIC CONSTIPATION A course of treatment for constipation with Laxatev 13.8 g does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's Disease, or induced by regular constipating medication in particular opioids and antimuscarinics. Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily. Children (below 12 years of age): Not recommended. Alternative products are available for children. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lugege kogu dokumenti